Precision Event Monitoring for Patients With Heart Failure Using HeartLogic
Completed
Conditions studied: Heart Failure, Defibrillators, Implantable, Monitoring, Physiologic, Cardiac Resynchronization Therapy, Cardiovascular Disease, Heart Disease
In brief
The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator. There are no primary safety and/or efficacy endpoints for this study. Heart failure is a complex clinical syndrome with high morbidity, mortality, and economic burden. Chronic Heart Failure is persistent, gradually progressive, and punctuated by episodes of acute worsening leading to hospitalizations. Therefore, there remains an unmet clinical need to slow the progression of Heart Failure and prevent hospitalizations. HeartLogic, available in Boston Scientific cardiac resynchronization therapy devices and defibrillators, combines novel sensor parameters such as heart sounds and respiration with other measurements like thoracic impedance, heart rate, and activity into a HeartLogic Index for the early detection of worsening Heart Failure. However, there is limited data on the association of HeartLogic with the risk of Hear Failure readmissions and tachyarrhythmias, or for phenotyping the broad spectrum of Heart Failure patients.
Key facts
- Study ID
- NCT03579641
- Run by
- Boston Scientific Corporation
- People needed
- 2184
- Starts
- 2018-06-01
- Expected to finish
- 2021-10-29
- Last updated by the study team
- 2022-10-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws.
- Subject has a documented diagnosis of heart failure.
- Subject has a Boston Scientific Cardiac Resynchronization Therapy Defibrillator or Implantable Cardioverter Defibrillator device implant that has HeartLogic, with Heart Failure Sensors turned ON, Respiratory Sensor turned ON, and Sleep Incline Sensor turned ON.
- Subject has an active bipolar right ventricle lead implant.
- Subject is enrolled in LATITUDE (NXT 5.0 or future version), and is willing to be remotely monitored from the baseline visit for approximately 12 months with HeartLogic disabled.
You may not qualify if…
- Subject has received or is scheduled to receive a heart transplant or ventricular assist device (VAD).
- Subject is enrolled in any concurrent clinical study without prior Boston Scientific written approval (excluding registries).
- Subject has a life expectancy of less than 12 months.
- Subject has a history of non-compliance to medical care or known inability to comply with requirements of the clinical study protocol
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Cardiology Associates of Northeast Arkansas — Jonesboro, Arkansas, United States
- Baptist Health Medical Center (Little Rock) — Little Rock, Arkansas, United States
- Providence St. Joseph Medical Center — Burbank, California, United States
- Mission Hospital — Mission Viejo, California, United States
- Stanford University Medical Center — Stanford, California, United States
- Harbor UCLA Medical Center — Torrance, California, United States
- Torrance Memorial Medical Center — Torrance, California, United States
- Cardiology Physicians, PA — Newark, Delaware, United States
- Baptist Medical Center — Jacksonville, Florida, United States
- Watson Clinic Center for Research, Inc. — Lakeland, Florida, United States
- Sarasota Memorial Hospital — Sarasota, Florida, United States
- Tallahassee Memorial Hospital — Tallahassee, Florida, United States
- Florida Hospital — Winter Park, Florida, United States
- CorVita Science Foundation (NFP) — Chicago, Illinois, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Evanston Hospital — Evanston, Illinois, United States
- St. John's Hospital — Springfield, Illinois, United States
- Carle Foundation Hospital — Urbana, Illinois, United States
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- University of Kansas Hospital — Kansas City, Kansas, United States
- Eastern Maine Medical Center — Bangor, Maine, United States
- University of Maryland Medical System — Baltimore, Maryland, United States
- Boston Medical Center — Boston, Massachusetts, United States
- Baptist Medical Center Princeton — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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